A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants

NCT00905840 | Completed Results

• 1 other identifier: CR 04/07
• Study Type: interventional
• Target: 91
• Locations: 5 countries
• Sites: 8

Brief Summary

The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.

Conditions

Jaw, Edentulous

Outcome Measures

Primary Outcomes (1)

• Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.

  Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material. The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used.

  12 months

Secondary Outcomes (2)

• Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990

  at 12, 24 and 36 months post surgery

• Soft Tissue and Safety Assessments

  after 12, 24, and 36 month

Study Arms (2)

Titanium Zircon implant

ACTIVE COMPARATOR

Intervention: each subject will receive two Straumann bone level implants, one implant is fabricated with Titanium Zircon and the other is a grade IV Titanium implant. Both implants will be randomly placed in the interforaminal region of the edentulous mandible, one on the right half and the other in the left part. Both implants will be treated the same way.

Device: Titanium Grade IV implant

Titanium Grade IV implant

PLACEBO COMPARATOR

Intervention: each subject will receive two Straumann bone level implants, one implant is fabricated with Titanium Zircon and the other is a grade IV Titanium implant. Both implants will be randomly placed in the interforaminal region of the edentulous mandible, one on the right half and the other in the left part. Both implants will be treated the same way.

Device: Titanium Zircon implant

Interventions

Titanium Zircon implant DEVICE

The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants. The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing.

Titanium Grade IV implant

Titanium Grade IV implant DEVICE

The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants. The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing.

Titanium Zircon implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have voluntarily signed the informed consent form
• Males and females must be 18 years of age.
• Patients must present with an edentulous mandible at the time of surgery.
• The last tooth or teeth in the mandible must have been extracted or lost more than 8 weeks before the date of first stage surgery.
• The opposing dentition must be edentulous with a denture (implant borne or conventional) or natural or restored teeth
• Adequate bone height of at least 9 mm above vital structures (because the minimal available implant lengths is 8mm) in the intraforaminal region. Available bone width should be in such way that 3.3 mm implants can be placed without the use of concurrent bone augmentation techniques. Harvested bone from the drilling sites may be used to cover minor dehiscence defects.
• Patients must be committed to participate in the study for three years of follow-up examinations

You may not qualify if:

• Medical conditions requiring prolonged use of steroids
• History of leukocyte dysfunction and deficiencies
• Patients with sever hemophilia
• History of head and neck radiation or chemotherapy
• Patients with history of renal failure
• The application of bisphosphonate medication
• History of uncontrolled endocrine disorders
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0.
• Alcoholism or drug abuse
• Patients with known infection of HIV
• Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
• Fertile females with no adequate method of birth control (contraceptive pill, barrier method, etc.)
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (8)

Catholic University Leuven School of Dentistry

Leuven, 3000, Belgium

Location

J. Gutenberg University, Oral and Maxillofacial Surgery

Mainz, 55131, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Universitá degli Studi di Milano

Milan, 20142, Italy

Location

Academic Center for Dentistry Amsterdam (ACTA)

Amsterdam, 1066 EA, Netherlands

Location

University Medical Center Groningen- UMCG

Groningen, Netherlands

Location

Université de Genève- Section médicine dentaire

Geneva, 1211, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Prof. Dr. Dr Bilal Al-Nawas, Principal Investigator
• Organization: Johannes-Gutenberg-University Mainz

al-nawas@mkg.klinik.uni-mainz.de

0049 6131 17

Study Officials

• Bilal Al-Nawas, PD Dr.

  J. Gutenberg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2011
• Last Updated: March 30, 2016
• Results First Posted: November 25, 2014

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (2); CH (2); NL (2); BE (1)